A Randomized, Double-blind, Placebo-controlled, Phase IIIb Trial (ATLAS) Comparing Bevacizumab Therapy with or without Erlotinib, after Completion of Chemotherapy.

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Presentation transcript:

A Randomized, Double-blind, Placebo-controlled, Phase IIIb Trial (ATLAS) Comparing Bevacizumab Therapy with or without Erlotinib, after Completion of Chemotherapy with Bevacizumab for 1st-line Treatment of Locally-advanced, Recurrent, or Metastatic Non-small Cell Lung Cancer (NSCLC)

Background & Rationale Adapted from: 1 Sandler A, et al., N Engl J Med 2006; 2 Shepherd FA, et al., N Engl J Med 2005; 3 Ciuleanu T, et al., ASCO 2008; 4 Herbst RS, et al., J Clin Oncol 2007; 5 Hainsworth J, et al., IASLC 2008.

ATLAS Study Design Carboplatin/paclitaxel; cisplatin/vinorelbine; carboplatin or cisplatin/gemcitabine; carboplatin or cisplatin/docetaxel.

ATLAS Objective

ATLAS: Randomized Patients by Region

ATLAS Statistical Considerations

ATLAS: Analysis Populations <2% of patients were lost to follow-up or withdrew consent. As of data cutoff date: 18 July *The randomized safety population consists of all randomized patients who received at least one dose of bevacizumab, erlotinib or placebo during the post-chemotherapy phase.

ATLAS: Baseline Characteristics (ITT population) *Patients randomized as of July 18, 2008.

ATLAS: Baseline Characteristics (cont.)

ATLAS Efficacy Results

ATLAS: Progression-free Survival (ITT population, investigator assessment)

ATLAS: Additional PFS Outcome Measures (ITT population)

ATLAS: Progression-free Survival in Subgroups *Includes <1% patients with ECOG PS 2.

ATLAS: Progression-free Survival in Subgroups (ITT population)

ATLAS: Preliminary Analysis of Subsequent Therapies Received (ITT population) *Pemetrexed was most commonly used.

ATLAS Safety Results

ATLAS: Summary for Post Chemotherapy Treatment Phase (Safety population) Formal statistical comparison testing between treatment arms was not done.

ATLAS: Causes of Death (Safety population) *Other causes of death reported by investigators: carcinomatous meningitis, breast cancer, respiratory failure, unexplained pneumonia.

ATLAS: Adverse Events of Special Interest during the Post-chemotherapy Phase (Safety population) Grade 5 events: Bevacizumab + Placebo: 1 (0.3%) CHF; Bevacizumab + Erlotinib: 2 (0.5%) Cardiovascular other than HTN, 1 (0.3%) ATE; 1 (0.3%) VTE.

ATLAS: Adverse Events of Special Interest (Cont.) Grade 5 events: Bevacizumab + Placebo: 1 (0.3%) infection. *Renal failure and hepatic events were reversible.

ATLAS Conclusions & Next Steps